Breast implants are a manufactured prosthesis used in cosmetic and reconstructive surgery. A breast implant has an outer casing or membrane that is filled with a fluid such as saline or a gelatinous cohesive silicone.
Only about thirty percent (30%) of breast implant procedures today use an insertion device. An insertion device shortens the duration of the surgical procedure and improves the surgery outcome. In regard to a cohesive silicone gel implant, without an insertion device, the surgeon makes the incision, creates a pocket for the implant, retracts the incision and then manually pushes the implant across the skin through the incision into the pocket.
Different than a silicone gel filled implant, a saline implant is inserted into the pocket in an empty configuration. Once placed in the pocket, the surgeon takes the additional step of filling the implant with a saline solution using a fill tube.
The incision is made in one of four places: in the armpit, in the breast fold, in the navel, or around the areola. Except for the navel insertion site, one incision is made for each implant. It is preferable that the incision be as short as possible. Shorter incisions are less unsightly. This goal of a shorter incision is easier to accomplish with a saline implant. A saline implant is relatively easy to insert through a short incision, because the implant is unfilled and therefore small in size as it passes through the incision. For these inflatable implants, the surgeon rolls up the implant like a cigar and pushes it through the incision into the pocket. In contrast, silicone implants are prefilled by the breast implant manufacturer resulting in a more difficult and complication-susceptible operation. For these pre-filled implants, the procedure requires a longer incision length.
After the initial incisions, the surgeon dissects a path through the tissue to the desired destination of the implant. Once that path has been created, a pocket is created for the implant superficial or deep to the pectoralis major muscle. The pocket may be formed in one of two places under the breast: subglandular (between the breast tissue and pectoralis major muscle) or subpectoral (under the pectoralis major muscle). Subglandular places the prosthesis directly behind the mammary gland and in front of the pectoralis major muscle. Subpectoral places the implant partially under the pectoralis major muscle. Due to the shape of the pectoralis major muscle, a portion of the implant is not covered by the muscle.
Secondary surgery is common for patients with breast implants. In particular, patients with breast implants may require surgery to change the placement (from subglandular to subpectoral or vice versa), correct palpable folding of the implant, remove a ruptured implant, treat infection, bleeding, breast pain, contracted scar tissue forming around the implant (capsular contracture) and collections of fluid around the implant. These additional surgeries have risks due to anesthesia, infection and bleeding. The overall secondary operation complication rate is almost 20% for silicone gel breast augmentation within 3 years of the initial operation and up to 36-45% by 10 years from the initial breast implant surgery. The majority of re-operations are related to capsular contracture, implant rupture (leakage), bleeding or infection or implant malposition.
Cellulitis, a skin-based infection occurring in 2%-4% of patients, is usually from bacteria normally present on the skin. Symptoms of infection include fever, pain, swelling and redness. To reduce infection, surgeons give a single dose of antibiotics before the surgery, and use an antibiotic solution in the wound before implant placement. The antibiotic solution may double as the lubrication to allow easier insertion of the implant into the pocket. However, surgeons can bring the rate of capsular contracture and infection down further by preventing the implant from touching the patient's skin.
The implant insertion devices heretofore known suffer from a number of disadvantages:                1. The device has two openings. The larger opening through which the implant is placed in the device is unsealed and the device cannot be sealed closed which allows the implant to inadvertently slip out of the larger open end of the device resulting in dropping the implant and/or contaminating the implant with skin bacteria.        2. The high cost of current implant devices encourages re-use despite the manufacturer recommendation not to do so.        